Kornimate/medical-research-clean huggingface dataset:
the effect of perineal massage in childbirth

Conditions: Obstetric Labor Complications

Summary: objective to examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth. methods the present study was a randomized controlled experimental. women (284 women) were informed on the study and provided their written consent. 10-minute perineal massage with glycerine was applied to the women in the test group for 4 times during the first stage and 1 time in the second stage of birth. the women in the control group received the routine care procedure at the clinic. results according to the study findings, 31% of the women in the test group and 69.7% of the women in the control group were made subject to episiotomy (p\ 0.05). the average duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the control group (p\<0.05). conclusion the study results indicate that perineal massage applied during the action of birth decreased the rate of episiotomy procedure and shortened the duration of the second stage of birth.


Eligibility criteria:
inclusion criteria: * with no pregnancy-related complications diagnosed during pregnancy, * no definitive indication for c-section, * satisfying the pregnancy week in terms of the fetal dimensions, * at the 37th-42nd gestation week, * applying to have her first or second birth, * with no systemic condition, * with head presentation, * at the latent phase of the first stage of birth with a dilatation under 4 cm and effacement below 50%, * that have provided written consent specifying their voluntariness in participating in the study. exclusion criteria: * with pregnancy-related complications diagnosed during pregnancy, * definitive indication for c-section, * no satisfying the pregnancy week in terms of the fetal dimensions, * at the \ 42nd gestation week, * with systemic condition, * with no head presentation, * at the latent phase of the first stage of birth with a dilatation above 4 cm * no have provided written consent specifying their voluntariness in participating in the study.

Keywords: perineal massage; episiotomy; perineal laceration
prevalence of malnutrition in surgery

Conditions: Malnutrition; Surgery; Cancer

Summary: nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. the prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. nutritional disorders represent an important risk factor for the occurence of postoperative complications. main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers. considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital. the promis study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in italy. the data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.

Eligibility criteria:
inclusion criteria: * patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver) * diagnosis of malignant solid tumor * age\> 18 years * informed consent exclusion criteria: * uncontrolled metabolic disorders * uncompensated heart failure * severe psychiatric disorders * appropriate logistical support for participation in the study.

Keywords: malnutrition post-operative complication
effect of re-esterified triglyceride (rtg) form omega-3 supplements on dry eye following cataract surgery

Conditions: Dry Eye

Summary: to evaluate the clinical outcomes of the systemic re-esterified triglyceride (rtg) form of omega-3 fatty acids in patients with dry eye symptoms after cataract surgery


Eligibility criteria:
inclusion criteria: * non complicated cataract surgery * patients with dry eye symptom exclusion criteria: * using steroid eyedops, * using antibiotics eyedrops * surgery other than cataract surgery * contact lens wearer * other systemic disease
the effectiveness of an attention-based intervention for school aged autistic children with anger regulating problems

Conditions: Autism Spectrum Disorder

Summary: children on the autism spectrum often show aggressive behavior. treatment can train children to be more aware of their emotions. investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems.

investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems. using a randomized controlled trial (rct), children were allocated to the attention-based treatment in combination with a psycho-educational parent-training (treatment group) or to the parent-training only (active control group).

Eligibility criteria:
inclusion criteria: * primary diagnosis of autism spectrum disorder * age 8 - 13 * seeking treatment for aggressive behaviour problems exclusion criteria: * psychotropic medication still being set

Keywords: autism spectrum disorder anger randomized controlled trial
oral iron supplementation with ferric maltol in patients with heart failure carrying left ventricular assist devices

Conditions: Heart Failure, Left Sided; Anemia, Iron Deficiency

Summary: this is a open-label, uncontrolled, monocenter, phase iv study. the aim of this study is to detect aes or saes with a relative frequency of at least 11.5% in lvad patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures 2. male and female patients ≥18 years at day of inclusion 3. patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial 4. patients that have an lvad implanted for chronic heart failure and which are clinically stable for at least 6 months after lvad implantation in the opinion of the investigator 5. 6 min walk distance \>50 m 6. mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and \<12 g/dl in females or ≥8 g/dl and \<13 g/dl in males, and serum ferritin \<100 µg/l, or 100-300 µg/l and transferrin saturation \<20% at screening 7. women of childbearing potential must: have a negative pregnancy test at screening agree to use reliable methods of contraception during the course of the study exclusion criteria: 1. active hematological disorders other than iron-deficiency anemia 2. other medical condition that according to the investigator's assessment is causing or contributing to anemia 3. active malignancy 4. active infectious disease 5. active bleeding 6. severe renal insufficiency (requiring dialysis) 7. severe liver injury as indicated by serum aminotransferases \>3 x upper limit of normal or bilirubin levels \>50 µmol/l 8. ongoing oral or intravenous iron supplementation 9. concomitant erythropoietin medication 10. pregnancy or lactation period 11. subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study. 12. known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product 13. known haemochromatosis or other iron overload syndromes 14. patients who have been receiving repeated (\>1) blood transfusions during the past 6 months

Keywords: iron deficiency
patients with epilepsy taking lamictal immediate-release who switch to extended-release formulation and vice versa

Conditions: Epilepsy

Summary: pharmacokinetic (pk) study to characterize changes in serum concentrations in epilepsy patients when switching from lamictal immediate-release to extended-release and vice versa.


Eligibility criteria:
inclusion criteria: * confident diagnosis of epilepsy. * currently on lamictal and up to 2 concomitant aeds (anti-epileptic drugs). exclusion criteria: * females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.

Keywords: once daily dosing seizure pharmacokinetics epilepsy
left bundle branch area pacing 3d guidance system

Conditions: Left Bundle Branch Pacing; Heart Failure; Bradycardia

Summary: the investigator's project proposes the development of a 3d hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay onto x-ray fluoroscopy imaging during left bundle branch pacing. the investigators hypothesise that the use of cardiac anatomy and myocardial scar distribution derived from cardiac magnetic resonance imaging (mri) as well as 3d position of the pacing lead, may improve lbbap lead deployment success and improve clinical outcomes by guiding the physician towards optimal lead positioning.

the study will use anonymised imaging data from the tactic-crt (iras 250715) , cardiac ct to guide cardiac resynchronisation therapy (crt) implantation (iras 150161) study (iras 150161) and anonymous cardiac mri, ct and fluoroscopy imaging data from patients who underwent lbba pacing to develop a 3d hybrid guidance system using machine learning methods. the developed 3d hybrid guidance system will be tested on anonymised retrospectively collected x-ray fluoroscopy images from patients who underwent lbbap and had a cardiac mri. the 3d hybrid guidance system will collect data from the retrospective anonymised x-ray fluoroscopic images, detect the pacing lead and reconstruct the 3d position of the pacing lead and test the accuracy of the 3d hybrid guidance system.

Eligibility criteria:
inclusion criteria: * all patients who took part in the tactic-crt (iras 250715) and cardiac ct to guide cardiac resynchronisation therapy (crt) implantation (iras 150161) study. * all patients who received a lbba pacing device from the gstt/rbh/ich database in the last 10 years (from 01/01/2014) and had a cardiac mri for assessment of scar. * all patients who are \>18 years old. * male and female exclusion criteria: * all patients \<18 years old * patients with congenital heart disease * patients who did not have a cardiac mri before receiving a lbba pacing device

Keywords: left bundle branch pacing pacemaker artificial intelligence conduction system pacing
intraoperative hemodynamics in cabg

Conditions: Coronary Artery Disease

Summary: the study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes.


Eligibility criteria:
inclusion criteria: * age18-80 for cabg surgery only exclusion criteria: * emergency surgery atrial fibrillation using ecmo/vad
autologous adipose tissue derived mesenchymal stem cells transplantation in patient with buerger's disease

Conditions: Buerger's Disease

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with buerger's disease.

buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most cases, affects young or middle-aged male cigarette smokers. it is characterized by narrowing or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced blood flow to these areas (peripheral vascular disease). the exact cause of buerger's disease is not known; however, most affected individuals are heavy tobacco users. this drug is an autologous cell treatment for necrosis in the legs of patients with beurger's diseases to improve symptoms through vascular regeneration.

Eligibility criteria:
inclusion criteria: * subjects who understand and sign the consent form for this study. * age :20-80, males and females * patients at least 6 months after buerger's disease * patients with a luminal stenosis of more than 50% on angiography * rutherford class ii-4, iii-5 or iii-6 * subjects not eligible to undergo a revascularization or vascular bypass graft * patients who can't treat with traditional medication and need a arthroplasty. * patients whose lesion is 2\~6 cm2 in size * duration of pain over grade 4(11-point numeric scale) : \> 4 months exclusion criteria: * subjects who cannot survive more than 6 months with critical other complications. * patient with well-known active malignant tumor. * patients who exceed normal reference values from following test : pap smear screening, chest x-ray, psa, mammogram, occult blood test * patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia * patients with uncontrolled iliac artery obstruction of targeted areas. * condition with targeted lower limb that have widespread necrosis or in need of amputation. * end-stage renal failure patients who depend on hemodialysis * patients with uncontrolled diabetes mellitus (hba1c \> 10%). * treatment with immunosuppressant (prednisone \> 5mg/day). * treatment with a anti-inflammatory drugs within 1 weeks prior to enrollment. * women who are pregnant or breast feeding or planning to become pregnant during the study. * subjects who have cerebrovascular accident within 6 months prior to inclusion in the study. * patients with acute myocardial infarction, angina pectoris. * subjects who had been underwent a cardiovascular surgery such as carotid endarterectomy, arterial aneurysm, bypass surgery and coronary bypass surgery within 3 months prior to inclusion in the study. * participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
body composition sub-study of the d2eft trial

Conditions: HIV Infections

Summary: this is a non-randomised, controlled, parallel group, sub-study of d2eft (nct03017872), a randomised, open-label study in approximately 1,000 hiv-infected adults failing first-line antiretroviral therapy (art) in low-middle income countries. the sub-study will be offered to all d2eft sites with access to dxa technology for whole-body composition analysis. sites will offer the sub-study to consecutive clinic patients. patients must be approached for participation and provide informed written consent prior to randomisation into d2eft. this study will recruit approximately 300 patients. allocation to one of three art treatment regimens will follow the result of d2eft randomisation. the study will investigate the role of contemporary art on body composition and metabolic parameters by comparing over 96 weeks the effects of the d2eft art regimens. the primary endpoint will be assessed at week 48.

consenting participants will be randomised within the main d2eft protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. enrolment into the sub-study is voluntary and not a requirement for enrolment into d2eft. parameters relevant to this study including demographics, arm of randomised art, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main d2eft study. sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy x-ray absorptiometry (dxa)-assessed whole-body composition. consenting participants will have blood for storage collected at weeks 0, 48 and 96. the specimens will be used for future studies into treatment of hiv infection and immunity.

Eligibility criteria:
inclusion criteria: * fulfil the criteria for d2eft randomisation * able to undergo dxa whole-body scanning * provide informed written consent for the d2eft body composition sub-study exclusion criteria: * unwilling to comply with the study requirements
acute effects of the prostaglandin (alprostadil) on cerebral and pulmonary flow

Conditions: Congenital Heart Disease

Summary: the second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (bcpc). the superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. a successful bcpc requires sufficient and easy blood flow through the lungs. alprostadil is the synthetic form of prostaglandin (hormone that causes dilation of blood vessels) and has been shown to increase blood flow in the brain hence increasing blood flow to the lungs after bcpc, potentially useful in managing children post bcpc with low flow to the lungs and thus poor oxygenation. this study propose to investigate acute effects of alprostadil on different blood vessels after bcpc.


Eligibility criteria:
inclusion criteria:• bcpc patients at time of routine pre-fontan assessment: cardiac catheterization and cardiac magnetic resonance imaging (cmr) • patients between the ages of 1 and 6 years old. exclusion criteria: * patients who are hypersensitive to this product or to any ingredient in its formulation. * patients with seizure disorders or coagulopathies. * patients with abnormal kidney function.
impact of treatment with alveogyl in patients with post-extraction dry socket

Conditions: Dry Socket

Summary: alveogyl (septodont, saint-maur-des-fossés - france) is a medical device used as dressing in case of dry socket. alve study is a clinical investigation measuring alveogyl performance and safety in patients with post-extraction dry socket. the study takes place in india and in france where alveogyl is already marketed, since 2010 in france and since 2014 in india .


Eligibility criteria:
inclusion criteria: * male or female patient, adult or child * positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature) * signed informed consent * in france only :patient affiliated to a health insurance scheme ("sécurité sociale") exclusion criteria: * spreading infection in the alveolar socket * placement of alveogyl done immediately after tooth extraction * multiple post-extraction dry sockets * patient treated with cervico-facial radiotherapy * immunodeficiency related to any diseases or current treatments * psychiatric patient or patient unable to assess his/her pain via the study pain vas * patient with history of hypersensitivity to one of the components * patient on post extraction of deciduous teeth * participation in another clinical investigation

Keywords: tooth extraction dry socket alveolar osteitis alveogyl surgical dressing
timing and intensity of the exposures and attributable burden of acute lung injury

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: the purpose of the study is to identify the patients at high risk of developing acute lung injury (ali) at the time of hospital admission, and before intensive care unit admission. aim 1- to validate the prediction model (lung injury prediction score) in a population based sample of hospitalized patients. aim 2- to determine the significance of health-care related ali risk modifiers in a population based sample. aim 3- to compare the short and long term outcomes between patients at high risk who do, and do not develop ali.

acute lung injury (ali) is an example of a critical care syndrome with limited treatment options once the condition is fully established.not surprisingly, many treatments targeting the mechanisms identified in preclinical studies have failed to improve patient outcomes.the most likely reason could be due to inadequate and delayed recognition of patients at risk and the subsequent development of the full blown syndrome.ali/ards usually develops during the first hours of icu admission, and often is the very reason for icu admission. clinical prediction models have been extensively used in the clinical practice to identify patients at high risks who may benefit from specific interventions. however, no such tool exists to predict the development of ali in patients at risk. we have recently developed an ali prediction model (lung injury prediction score:lips)which incorporates demographic, environmental and clinical characteristics at the time of, and before, hospital admission. if validated, this model will serve to find the population of patients at high risk of ali in whom future prevention trials will be conducted. by determining not only patients at high risk but also the attributable burden of ali/ards in contemporary cohorts of patients at risk, our findings will facilitate the prioritization of preventive strategies and future clinical trials.

Eligibility criteria:
inclusion criteria: * all olmsted county residents more than 18 years of age who were admitted to the two mayo clinic rochester hospitals exclusion criteria: * denied the use of medical records for research * acute lung injury or pulmonary edema already present at the time of hospital admission * admitted for comfort or hospice care only * children * hospital readmission * patients admitted for cardiac telemetry, coronary care unit, low risk elective surgeries, labor and delivery

Keywords: acute lung injury acute respiratory distress syndrome respiratory distress pneumonia sepsis aspiration pancreatitis